Systems and methods for biometric data collections

ABSTRACT

A biometric biochemical analysis system includes a user interface module to provide instructions for collecting and handling biochemical sampling and processing related to biometric data gathering as well as capturing biometric data using digital data capturing devices. The user interface module and display are integrated with analysis and communications portions of the biometric biochemical analysis system to provide a portable system for multi-portion data collecting, storage, verification, and analysis.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority from U.S. provisional patentapplication 62/067,429 filed on Oct. 22, 2014.

This application is related to the following applications assigned toIntegenX Inc.: U.S. provisional application Ser. No. 62/067,404 entitled“Systems And Methods For Sample Preparation, Processing And Analysis”(Kindwall, et al.), filed Oct. 22, 2014; and U.S. provisionalapplication Ser. No. 62/067,120 entitled “Fluidic Cartridge With ValveMechanism” (Eberhart, et al.), filed Oct. 22, 2014.

Each of these applications are incorporated herein by reference in theirentirety. Furthermore, all referenced documents and application hereinand all documents referenced therein are incorporated herein byreference for all purposes. This application may be related to otherpatent applications and issued patents assigned to the assigneeindicated above. These applications and issued patents are incorporatedherein by reference to the extent allowed under applicable law.

COPYRIGHT NOTICE

Pursuant to 37 C.F.R. 1.71(e), applicant notes that a portion of thisdisclosure contains material that is subject to and for which is claimedcopyright protection (such as, but not limited to, source code listings,screen shots, user interfaces, or user instructions, or any otheraspects of this submission for which copyright protection is or may beavailable in any jurisdiction.). The copyright owner has no objection tothe facsimile reproduction by anyone of the patent document or patentdisclosure, as it appears in the Patent and Trademark Office patent fileor records. All other rights are reserved, and all other reproduction,distribution, creation of derivative works based on the contents, publicdisplay, and public performance of the application or any part thereofare prohibited by applicable copyright law.

FIELD OF THE INVENTION

The present invention relates to logic systems. More particularly, itrelates to control systems, computer systems and associated systems andmethods that facilitate the collection, processing, analysis and/orvalidation of biometric data. In further embodiments, one or moremethods may be implemented on a data handling device or system, such asa computer or other information enabled device. In further embodiments,methods and/or systems for performing one or more analysis over acommunication network are provided. In further embodiments, theinvention relates to integrated automated fingerprint identificationssystems.

BACKGROUND OF THE INVENTION

The discussion of any work, publications, sales, or activity anywhere inthis submission, including in any documents submitted with thisapplication, shall not be taken as an admission that any such workconstitutes prior art. The discussion of any activity, work, orpublication herein is not an admission that such activity, work, orpublication existed or was known in any particular jurisdiction.

SUMMARY

According to specific embodiments, methods and/or systems and/or devicesare described that can be used together or independently to provideimproved collection, processing, analysis, and/or validation ofbiometric data and optionally related data at a processing location. Inspecific embodiments, methods and/or systems and/or devices facilitateand/or direct workflow to allow non-technical users to collect andvalidate electronically captured biometric data (e.g. fingerprints,photographs, voice-prints, retinal-scans, etc.), biochemical biometricdata (e.g., DNA or protein or other chemically analyzable data) andrelated data (name, address, identification numbers, etc.). In furtherembodiments, a system or method is described that provides improvedinteraction between a biometric data collection and processing systemand one or more server systems or databases (e.g. generally remotesystems accessible over the Internet or other networks, e.g. centralcrime registry database, identification databases, etc.). In specificembodiments, novel systems and methods for user interaction with abiometric data collection system are provided. In other embodiments,novel systems and methods for biometric data collection and biologicalsample collecting and analysis are provided.

One system according to specific embodiments, referred at times hereinas the “Rapid DNA analyzer” can, among other features, provide workflowimprovement for collection of biometric data generated by an analysisdone by the system (e.g., DNA analysis data by electrophoresis) alongwith collection and verification of integrated captured biometric data(e.g. fingerprints, photographs, retinal scans, voice prints, etc.)

According to specific embodiments, a system (e.g., a Rapid DNA analyzer)can be used to capture prints (e.g., a ten-print, a thumb print, etc.)from an arrestee or detainee at time of booking or detention. The printcan then be searched against a local or remote database such as the NextGeneration Information (NGI) system used by the FBI. The remotefingerprint database can also contain information indicating whether theperson has had a DNA sample taken.

According to further specific embodiments, if the system's ten-printcapture interface is used to capture the fingerprints, on confirmationfrom an on-system database, rather than again querying the remotedatabase, the system can match the confirmation fingerprint with theten-print that it had acquired, saving time to begin processing the DNAsample, and saving capacity for the remote database.

According to further specific embodiments, the user interface portion ofsystem is touchless, indicating that the system receives commands andinstructions via audio input or camera input to log on or toauthenticate a user via face recognition. For example, the system can“wake up” and/or log a user on or authenticate a user when a voicecommand is detected or an authorized user positions himself such thatthe system can capture a facial image.

In further embodiments, a system communicates with a database, such as acriminal records data base, and automatically responds back to a user ofthe system if there is a match with, for example, a person wanted by alaw enforcement agency.

In other embodiments, the system includes operative elements located inpredetermined positions that are known to the system. These elements caninclude, for example, a camera, microphone, fingerprint reader, samplecartridge slot, etc. The user interface can display graphically thepositions of specific elements when instructing a user to take actions.

US Patent application 20130115607 (Priority date Oct. 21, 2011, alsopublished as WO2013059750A1) describes an integrated and automatedsample-to-answer system that, starting from a sample comprisingbiological material, generates a genetic profile in less than two hours,for example where the biological material is DNA and the genetic profileinvolves determining alleles at one or a plurality of loci (e.g.,genetic loci) of a subject, for example, an STR (short tandem repeat)profile, for example as used in the CODIS system. The system can performseveral operations, including (a) extraction and isolation of nucleicacid; (b) amplification of nucleotide sequences at selected loci (e.g.,genetic loci); and (c) detection and analysis of amplification product.These operations can be carried out in a system that comprises severalintegrated modules, including an analyte preparation module; a detectionand analysis module and a control module.

Various embodiments of the present invention provide methods and/orsystems for biometric data interaction over a communications network.According to specific embodiments of the invention, a client system isprovided with a set of interfaces that allow a user to view, collect,validate, etc. biometric data. The client system presents informationregarding the data and presents indications or instructions regardingactions to a user and displays an indication of an action that a user isto perform to complete the next step of the workflow. In response to auser action and completion of appropriate workflow steps, the clientsystem sends to a server system the necessary information to access orprocess or verify biometric data. The server system uses the requestdata, and optionally one or more sets of server data, to process therequest. According to specific embodiments of the present invention, aclient system is, or has previously been, provided with an executablecode file that allows the client system to operate as described herein.

Thus, in further embodiments, the present invention may be understood inthe context of facilitation biometric data collection and verificationwith communication to external data storage or analysis systems over acommunication media. An important application for the present invention,and an independent embodiment, is in the field of exchanging biometricdata over the Internet or private networks, optionally using Internetmedia protocols and formats, such as HTTP, RTTP, XML, HTML, dHTML, VRML,as well as image, audio, or video formats etc. However, using theteachings provided herein, it will be understood by those of skill inthe art that the methods and apparatus of the present invention could beadvantageously used in other related situations where users accesscontent over a communication channel, such as modem access systems,institution network systems, wireless systems, etc.

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

Additional aspects and advantages of the present disclosure will becomereadily apparent to those skilled in this art from the followingdetailed description, wherein only illustrative embodiments of thepresent disclosure are shown and described. As will be realized, thepresent disclosure is capable of other and different embodiments, andits several details are capable of modifications in various obviousrespects, all without departing from the disclosure. Accordingly, thedrawings and description are to be regarded as illustrative in nature,and not as restrictive.

Further in light of the above, specific embodiments can involve systems,methods, or components containing any combination of elements describedbelow. Specific embodiments involve a system comprising anauthentication sub-system with a camera and/or a microphone, and abiochemical analysis sub-system configured to perform a biochemicalanalysis on a biological sample provided to the biochemical analysissub-system; with the system configured to: (a) authenticate a user byfacial recognition based on one or more images taken by the camera or byvoice recognition based on voice sound picked up by the microphone,wherein authentication proceeds without an active command from the user;(b) instruct an authenticated user to provide a biological sample to thebiochemical analysis sub-system; (c) without further user input,automatically execute a biochemical analysis on a provided biologicalsample.

Further embodiments involve automatic execution of the biochemicalanalysis based on instructions stored in system memory, instructionsstored on readable memory in the cartridge, or a combination of both.Specific embodiments involve the biological sample provided by insertionof a sample cartridge into a receptacle of a biochemical analysissub-system. In other embodiments, the authentication system comprises aprocessor and memory, wherein the memory includes (i) a database ofauthorized users with authenticating information and (ii) instructionsexecutable by the processor to authenticate authorized users based onimages taken by the camera.

In further embodiments, a camera of the system periodically orcontinually scans the environment for a user that can be authenticated.In other embodiments, the biochemical analysis comprises performing abiochemical reaction on an analyte in the biological sample to produce areaction product and perform a detection or measurement on the reactionproduct. In other embodiments, the system is further configured totransmit a result of the biochemical analysis to a remote server and/orto display the result to the authenticated user.

Further embodiments involve one or more digital biometric data capturedevices; wherein the system is further configured to instruct theauthenticated user to electronically capture biometric data from asubject using at least one of the digital biometric data capturedevices. In further embodiments, the digital biometric capture devicecomprises a camera, a fingerprint reader or a retinal scanner.

Methods according to specific embodiments comprise without an activecommand from a user, using an authentication sub-system of a system tocollect one or more camera images of a user and authenticating the basedon the images; instructing an authenticated user through a userinterface on the system to provide a biological sample to a biochemicalanalysis sub-system of the system; and without further user input,automatically executing a biochemical analysis on a provided biologicalsample.

In further embodiments, biochemical analysis comprises detecting ormeasuring an analyte in the biological sample directly or indirectly(e.g., by performing a biochemical reaction on the analyte to produce aproduct, and detecting or measuring the product).

Other embodiments involve a method of collecting biometric data from oneor more subjects comprising configuring a biometric capture andbiochemical analysis system having at least one logic processor, datastorage, at least one biological sample receiver, at least oneelectronic biometric data capture interface, at least one biochemicalanalyzer, at least one communications interface, and at least one userpresentation interface to perform steps comprising using the userpresentation interface to direct a user to prepare a biologic sampleand/or to place a biologic sample into a receptacle of the biometricbiochemical analysis system; using the user presentation interface todirect said user or a different user to collect electronically capturedbiometric data from a subject using one or more digital biometric datacapture devices; performing a biochemical analysis of the sample usingthe biochemical analyzer to produce a set of biochemical biometric data;and storing results indicating biochemical biometric data orelectronically captured biometric data or both in system memory and/orcommunicating the results to one or more additional computer systemsover the communications interface. Further embodiments involve one ormore of executing instructions on the logic processor to authenticate auser; using the user presentation interface to direct a user to collecta biologic sample from one or more subjects. Samples can be one or moreselected from saliva, blood, semen, hair, tissues, bodily fluids, anon-living substance suspected of being contaminated with DNA, a swab orother instrument used to sample substances suspected of containing DNA.In further embodiments, the one or more subjects can be one or moreselected of: a person being detained, a newborn; a living or deceasedvictim of an accident or natural disaster, a living or deceased casualtyof a military action; a living or deceased victim of a crime or otheract of violence; a living or deceased unidentified person; any person;domesticated animals such as livestock, racing animals, pets; wildanimals such as research subjects or fisheries catch.

In other embodiments one or more capture devices can be one or more of astill camera; a video camera; an infrared camera or other heat detectingor imaging devices; a scanner for scanning finger prints, hand prints,or foot prints; a retina scanner; a facial scanner; and a microphone forrecording audio data. In further embodiments, one of the one or morecapture devices are integrated into the biometric biochemical analysissystem so as to have a fixed positional relationship to other componentsof the biometric biochemical analysis system. In specific embodiments atleast one of the one or more capture devices are connected to thebiometric biochemical analysis system through a local wired or wirelessconnection so as to allow some independent movement or positioning ofthe capture device with respect to other components of the biometricbiochemical analysis system.

According to further specific embodiments, prior to collecting abiologic sample or one or more items of digitally captured biometricdata, querying a database to determine if a subject is known to thedatabase and using whether a subject is known and information aboutbiometric or biological data already on record for the subject to adjustuser prompts to direct a user to only capture biometric data or collecta sample when needed or authorized. Specific embodiments allowing one ormore users to collect data in an overlapping fashion such that while thebiometric biochemical analysis system is performing an analysis orwaiting for data from another source, a first user, or an additionaluser, can receive instructions for collecting digitally capturedbiometric data or can receive instructions for collecting one or moreadditional biologic samples for further subjects.

According to specific embodiments, the user presentation interfacecomprises a display on the biometric biochemical analysis system anddirecting the user to prepare and/or place a biologic sample comprisesdisplaying textual or graphical instructions on the display directingspecific sample preparation and collection actions and deposit of thesample into a receiver. In other embodiments, directing the user toprepare and/or place a biologic sample comprises one or more positionalindications alerting a user as to where to place a sample or take someother action with respect to the biometric biochemical analysis systemduring particular steps of the collection. In further embodimentsdirecting the user to prepare and/or place a biologic sample furthercomprises presenting one or more step by step instructions to a user,wherein the step by step instructions include at least one instructionspecifically indicating a location of a receiver for a sample. In otherembodiments, said one or more actions to prepare and/or place a biologicsample comprises: taking a biologic sample from a subject, interactingwith the biometric biochemical analysis system to associate the biologicsample with a subject identifier stored by the biometric biochemicalanalysis system, placing the biologic sample into the sample receivermodule.

In other embodiments, the user presentation interface comprises an audiooutput interface and said directing the user to collect a biologicsample comprises presenting audio prompts to a user either from aspeaker on the biometric biochemical analysis system or through aninterface directed to a speaker or directed to headphones worn by auser.

In other embodiments, directing the user to prepare and place a biologicsample comprises one or more positional indications alerting a user asto where to position a sample with respect to the biometric biochemicalanalysis system during particular steps of the collection.

Other specific embodiments are configured for detecting a need forreplacement or refilling of one or more components of the system anddirecting a user via the user presentation interface to perform steps toaccomplish the replacement or refilling or detecting a need for arecalibration or revalidation of one or more components of the systemand directing a user via the user presentation interface to performsteps to accomplish the recalibration or revalidation or both.

In other embodiments, the system is configured for directing andautomating the capture of one or more sets of biometric associated datasuch as name, address, identification number, incident report, locationor condition of subject when found or identified by providing userinstructions and indicating capture modules or interfaces using one ormore of: audio recording; voice to text recognition; documentphotographing or scanning; OCR, etc.; and for generating data orinstructions for preparing one or more identification labels (e.g.,printed labels, printed labels with bar codes; RFID or electroniclabels) to attach to a subject; a subjects possessions; other associatedobjects or substances; or evidence; thereby providing in one system acomplete automated process for handling biometric data and associateddata of subjects and identifying and labeling further objects; evidence;or possessions associated with subjects.

According to specific embodiments, a system or method as discussedherein involves a system that is substantially portable or transportableand can be moved in a passenger vehicle for biometric data collectionand processing in various theaters of operation.

According to further specific embodiments, a system comprises at leastone logic processor; data storage; at least one biological samplereceiver; at least one electronic biometric data capture module; atleast one biochemical analyzer module; at least one communicationsmodule; and at least one user presentation module. The processor isconfigurable with logic instructions to enable the system to performmethods as described herein. In specific embodiments, a method comprisesusing the user presentation module to direct said user or a differentuser to collect electronically captured biometric data from a subjectusing the digital biometric data module; using the user presentationmodule to direct a user to place a biologic sample into a biologicalsample receiver and/or to prepare a biologic sample; performing abiochemical analysis of the sample to produce a set of biochemicalbiometric data; and communicating results indicating biochemicalbiometric data or electronically captured biometric data or both to oneor more additional computer systems over the communications interface.In specific embodiments the at least one biological sample can be one ormore of: a cartridge receiver; a cartridge receiver and a cartridge; aliquid sample receiver; a solid sample receiver. In specificembodiments, the least one electronic biometric data capture module canbe one or more scanners or cameras for capturing images or scanning datafrom one or more of: a face or any other part of a body or clothinguseful in identification including one or more of prints of fingers,palms, feet, toes, a sample or a sample with a bar code, RFID code, orother code, and an identification card or birth certificate or deathcertificate or other papers, a retinal scan. According to specificembodiments, one or more audio recorders for capturing a voice print orother audio data and/or one or more interfaces for attaching to externaldata capture devices can be included.

In further embodiments, electronic biometric data capture modules can beone or more of a still camera, a video camera, an infrared camera orother heat detecting or imaging devices, a scanner for scanning fingerprints, hand prints, or foot prints, a retina scanner, a facial scanner,a microphone for recording audio data. or one or more interfaces toconnecting to any external capture device. According to specificembodiments, an analyzer can be one or more of: an electrophoresisanalyzer; one or more other analyzers or detectors; one or more samplecartridge interfaces; one or more interfaces for attaching to externalanalyzers or detectors.

In specific embodiments, the logic processor is configured to executeinstructions to perform a biochemical reaction on a sample in a samplecartridge engaged with the cartridge interface to produce a reactionproduct and to analyze the reaction product.

In other embodiments, at least one additional analyzers or detectors areincluded and can be one or more of one or more medical examinationdetectors able to determine one or more of heart rate, temperature,blood pressure, or other medical parameters; one or more detectors fordetecting drugs or alcohol or other parameters from body sample such ashair, blood, skin, or urine; one or more detectors for detecting drugsor alcohol or other parameters from a breath sample.

A communication interface according to specific embodiments can be oneor more of a wired or wireless connection to a local area network; awired or wireless connection to an external connection, such as theinternet; and a wired or wireless connection to one or more localdevices or systems. A user presentation interface according to specificembodiments can be one or more of multipurpose displays for presentingvideo, image, or text content, audio devices, more visual or audioindicators for indicating a state of a particular part of component ofthe system, interfaces for external presentation devices. In furtherembodiments, system components are operationally connected intoeffectively one system with a user presentation interface configured todirect collection of both a sample and to capture biometric data and/orconfigured into a physical housing that provides a substantially unifiedphysical system.

In various embodiments, the processor is configurable to use one or moreof the modules to authenticate a user and/or to use one or more of saidmodules to direct a user to collect a biologic sample from one or moresubjects.

Various embodiments involve samples that are one or more of saliva,blood, semen, hair, tissues, bodily fluids, a non-living substancesuspected of being contaminated with DNA, a swab or other instrumentused to sample substances suspected of containing DNA and/or subjectsthat are one or more selected of a person being detained, a newborn; aliving or deceased victim of an accident or natural disaster, a livingor deceased casualty of a military action; a living or deceased victimof a crime or other act of violence; a living or deceased unidentifiedperson; any person; domesticated animals such as livestock, racinganimals, pets; wild animals such as research subjects or fisheriescatch.

In further embodiments the at least one electronic biometric datacapture module comprises one or more capture devices integrated into thebiometric biochemical analysis system so as to have a fixed positionalrelationship to other components of the biometric biochemical analysissystem and/or one or more capture devices connected to the biometricbiochemical analysis system through a local wired or wireless connectionso as to allow some independent movement or positioning of the capturedevice with respect to other components of the biometric biochemicalanalysis system.

In further embodiments, the processor is further configurable to priorto collecting a biologic sample or one or more items of digitallycaptured biometric data, query a database to determine if a subject isknown to the database and using whether a subject is known andinformation about biometric or biological data already on record for thesubject to adjust user prompts to direct a user to only capturebiometric data or collect a sample when needed or authorized and/or toallow one or more users to collect data in an overlapping fashion suchthat while the biometric biochemical analysis system is performing ananalysis or waiting for data from another source, a first user, or anadditional user, can receive instructions for collecting digitallycaptured biometric data or can receive instructions for collecting oneor more additional biologic samples for further subjects.

According to specific embodiments. the processor is further configurableto use the user interface to direct the user to prepare and place abiologic sample comprises displaying textual or graphical instructionson the display directing specific sample preparation and collectionactions and deposit of the sample into a receiver and in specificembodiments, directing the user to prepare and place a biologic samplecomprises one or more positional indications alerting a user as to whereto place a sample or take some other action with respect to thebiometric biochemical analysis system during particular steps of thecollection and/or directing the user to prepare and/or place a biologicsample by presenting one or more step by step instructions to a user,wherein the step by step instructions include at least one instructionspecifically indicating a location of a receiver for a sample. Inspecific embodiments, one or more actions to prepare and place abiologic sample involve taking a biologic sample from a subject,interacting with the biometric biochemical analysis system to associatethe biologic sample with a subject identifier stored by the biometricbiochemical analysis system, placing the biologic sample into the samplereceiver module. In other embodiments, an audio output interface candirect the user to collect a biologic sample comprises presenting audioprompts to a user either from a speaker on the biometric biochemicalanalysis system or through an interface directed to a speaker ordirected to headphones worn by a user. In other embodiments, directingthe user involves one or more positional indications alerting a user asto where to position a sample with respect to the biometric biochemicalanalysis system during particular steps of the collection.

Further embodiments involve a method incorporating any combination ofthe elements described above or a system configured to carry out amethod incorporating any combination of the elements described inparagraphs [0023] to [0043] above. Other embodiments involve anontransitory computer readable medium containing computer interpretableinstructions that when loaded into an appropriately configuredinformation processing device will cause the device to operate inaccordance with a method incorporating any combination of the elementsdescribed in paragraphs [0023] to [0043] above.

Other embodiments involve a method or a system for collection andanalysis of biometric data from subjects by non-technical users at anintegrated biometric data collection and analysis system, the systemcomprising a logic processor operationally connected to: a memory, auser interface, a biometric data collection component, a biologicalsample receiver, a biochemical analysis component, and a communicationscomponent, the method comprising: configuring the at least one logicprocessor of the system to execute a logic routine able to: authenticatea user using the user interface; direct the user using the userinterface to input initial data regarding a subject using the userinterface or the biometric data capture component or both; perform aninitial search using the initial data and indicate to a user progress ofthe initial search using the user interface; determine if a biometricsample should be collected and, if yes, direct the user using the userinterface how to do any of: collect the biologic sample, identify thesample to the system, or place the sample into the biological samplereceiver for biologic analysis; on completion of a biologic analysis,transfer biologic analysis data results for forensic identification;optionally, indicate to a user progress of the biologic analysis andprogress of the transfer using the user interface; optionally, indicateto a user when to remove the sample from the system and further handlingof the sample; receive data regarding forensic identification; andpresent data regarding forensic identification to the user using theuser interface.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features according to specific embodiments are set forth withparticularity in the appended claims. A better understanding of thefeatures and advantages will be obtained by reference to the followingdetailed description that sets forth illustrative embodiments and theaccompanying drawings (also “figure” and “FIG.” herein), of which:

FIG. 1A-C are flow charts illustrating methods of collecting biometricdata according to specific embodiments of the invention.

FIG. 2 is a photograph showing example external features and appearanceof a biometric biochemical analysis system according to specificembodiments.

FIG. 3A-C illustrate features and aspects of example biometricbiochemical analysis systems according to specific embodiments.

FIG. 4A-4AB illustrate a series of example graphical user interfacescreens that are displayed on a biometric biochemical analysis systemdisplay according to specific embodiments.

FIG. 5 is a block diagram showing a representative example logic devicein which various aspects of the present invention may be embodied.

FIG. 6 shows a computer system that is programmed or otherwiseconfigured to provide step by step user instructions for biologic samplecollection and analysis and biometric data capture preparation,processing and/or analysis.

DESCRIPTION OF SPECIFIC EMBODIMENTS

Before describing the present invention in detail, it is to beunderstood that this invention is not limited to particular compositionsor systems, which can, of course, vary. It is also to be understood thatthe terminology used herein is for the purpose of describing particularembodiments only, and is not intended to be limiting. As used in thisspecification and the appended claims, the singular forms “a”, “an” and“the” include plural referents unless the content and context clearlydictates otherwise. Thus, for example, reference to “a device” includesa combination of two or more such devices, and the like.

Unless defined otherwise, technical and scientific terms used hereinhave meanings as commonly understood by one of ordinary skill in the artto which the invention pertains. Although any methods and materialssimilar or equivalent to those described herein can be used in practiceor for testing of the present invention, the preferred materials andmethods are described herein.

While various embodiments of the invention have been shown and describedherein, it will be obvious to those skilled in the art that suchembodiments are provided by way of example only. Numerous variations,changes, and substitutions may occur to those skilled in the art withoutdeparting from the invention. It should be understood that variousalternatives to the embodiments of the invention described herein may beemployed.

Whenever the term “at least” or “greater than” precedes the firstnumerical value in a series of two or more numerical values, the term“at least” or “greater than” applies to each one of the numerical valuesin that series of numerical values.

Whenever the term “no more than” or “less than” precedes the firstnumerical value in a series of two or more numerical values, the term“no more than” or “less than” applies to each one of the numericalvalues in that series of numerical values.

The term “sample”, as used herein, refers to a sample containingbiological material. A sample may be, e.g., a fluid sample (e.g., ablood sample) or a tissue sample (e.g., a cheek swab). A sample may be aportion of a larger sample. A sample can be a biological sample having anucleic acid, such as deoxyribonucleic acid (DNA) or ribonucleic acid(RNA), or a protein. A sample can be a forensic sample or anenvironmental sample. A sample can be pre-processed before it isintroduced to the system; the preprocessing can include extraction froma material that would not fit into the system, quantification of theamount of cells, DNA or other biopolymers or molecules, concentration ofa sample, separation of cell types such as sperm from epithelial cells,concentration of DNA using an Aurora system (Boreal Genomics) or beadprocessing or other concentration methods or other manipulations of thesample. A sample can be carried in a carrier, such as a swab, a wipe, asponge, a scraper, a piece punched out a material, a material on which atarget analyte is splattered, a food sample, a liquid in which ananalyte is dissolved, such as water, soda. A sample can be a directbiological sample such as a liquid such as blood, semen, saliva; or asolid such a solid tissue sample, flesh or bone.

Systems discussed herein can also be applied to process and analyze asample that has been previously preprocessed, for example, by extractionof DNA from large object such as a bed sheet or chair and otherprocessing which may include quantification of DNA concentration, cellconcentration, or other manipulations before input of the pre-processedsample into the sample cartridge of the system. DNA can be analyzed byamplification (e.g., PCR) followed by capillary electrophoresis or byDNA sequencing, e.g., high throughput sequencing.

“Biometric data” as used herein generally refers to any data used toidentify an individual, group of individuals, or any biologic entity orgroup that is a measurement or image of a biologic system. For purposesof this discussion, biometric data comprises without limitation,fingerprints, hand and foot prints, facial or body recognition, DNA orprotein recognition, blood or tissue recognition, voice prints or vocalrecognition, dynamic or static signature information, gait recognition,height, weight, dental records or x-rays, etc. “Biometric data” can alsoencompass other identifying information, such as date of birth,government issued ID number, etc.

“Digitally captured biometric data” as used herein generally refers toany data used to identify an individual, group of individuals, or anybiologic entity or group that is a measurement or image of a biologicsystem that is generally directly captured from a subject as digitaldata without requiring substantially further analysis or processing. Forpurposes of this discussion, biometric data comprises withoutlimitation, fingerprints, hand and foot prints, facial or bodyrecognition, voice prints or vocal recognition, dynamic or staticsignature information, gait recognition, height, weight, dental recordsor x-rays, etc. “Biometric data” in some contexts can also encompassother identifying information, such as date of birth, government issuedID number, etc.

“Biochemical biometric data” as used herein generally refers to any dataused to identify an individual or any biologic entity or group that isthat is based on detecting one or more chemical or biologicalproperties. For purposes of this discussion, “biochemical biometricdata” biometric data comprises without limitation, DNA or proteinrecognition, blood or tissue recognition, or other chemical orbiological substance analysis. For example, biochemical biometric datacan include short tandem repeat (STR) profiles, genetic ancestryprofiles and genomic sequence data.

Overview

According to specific embodiments, data processing or information orcomputer systems and/or methods and/or operational methods that can beused together to as described herein. Systems and methods as describedherein in various embodiments and some of the benefits and features ofthese embodiments can be understood as including any combining of thefollowing: (1) integration and automation of previously disparateworkflows; (2) higher confidence of chain of custody of biometric data;(3) portability; (4) ease of use; (5) decreased costs; (6) increasedspeed; (7) increased efficiency; and (8) configurable operation to allowoptimizing workflow in different operating environments (booking room,hospital, disaster site, morgue, etc.) and in different legal orprocedural regimes (e.g., legal restrictions on when and whether DNAsamples may be taken, legal requirements for video documenting one ormore steps of biometric data or sample gathering, institutional or legalrequirements for preserving, linking, or verifying specific types ofbiometric data and associated data generated during a data collectionprocess, etc.)

In one embodiment, the present invention provides a method and/or systemfor biometric data collection and verification in a client/serverenvironment.

Systems

Recognized herein is the need for highly integrated and automatedsystems and methods for collecting digitally captured and biochemicalbiometric data, including instructing users on digital capture, samplecollection, sample preparation, and on automatically processing andanalysis. Systems provided herein may be capable of preparing,processing and analyzing a single sample or a plurality of samples.Several automated sample handling operations can be performed by thesystem provided herein, for example, (a) receiving one or more samples;(b) isolating and extracting target material from the received sample;(c) purifying and amplifying the whole target material or selectiveportion of the target material to produce an analyte ready to beexamined; and (d) separating, detecting and analyzing the preparedanalyte. These operations can be conducted and performed in a systemthat comprises several integrated sub-systems, for example, at leastabout 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, or 50 sub-systems. Insome cases, a system may comprise a user interface, a sample cartridgeinterface, and an electrophoresis interface. The sample cartridgeinterface and the electrophoresis interface are configured to releasablyengage with a sample cartridge for sample processing, and anelectrophoresis cartridge for sample analysis respectively. Systemsprovided herein can be fully automated, enabling a user to receive,process and analyze a sample without substantial labor and input. Samplepreparation, processing and analysis can be accomplished in providedsystems without the necessity of manually removing and transferring thesample, reagents and analytes among different parts in the system. Sincethe incorporated sub-units (e.g., sample cartridge and electrophoresiscartridge) are highly integrated and bear small sizes, systems providedherein can be dimensioned to minimize footprint, enabling theportability and usefulness in a wide context of applications. Forexample, the systems may be used in on-the-go situations, such as remotelocations. Or they may be used in situations in which transportation isnot readily available or user mobility is desired, such as battlefieldsscenarios.

FIG. 3A-C illustrate features and aspects of example biometricbiochemical analysis systems according to specific embodiments FIG. 3Aillustrates a system for sample processing and analysis. System 1900 caninclude several functional elements. System 1900 can include a samplepreparation sub-system, a sample analysis sub-system and a controlsub-system. A sample preparation sub-system of the system 1900 caninclude a sample cartridge interface 1501 configured to engage a samplecartridge 102, sources of reagents for performing a biochemicalprotocol, a fluidics assembly configured to move reagents within thesample preparation sub-system. A fluidics assembly can include a pump,such as a syringe pump. The pump is fluidically connectable throughvalves to the outlets for reagents such as water and lysis buffer and toa source of air. The pump can be configured to deliver lysis buffer andwater through fluidic lines 1910 and 1911, respectively, to inlet port1912 in the sample cartridge. Air or liquid pressure applied by the pumpto inlet port 1912 can pump analyte out outlet port 1913 and throughline 1912 into the analyte inlet in the electrophoresis cartridge.

Electrophoresis is the motion of dispersed particles relative to a fluidunder the influence of a spatially uniform electric field. It may becaused by the presence of a charged interface between the particlesurface and the surrounding fluid. Electrophoresis is the basis for anumber of analytical techniques used in biochemistry for separatingmolecules by size, charge, or binding affinity.

FIG. 3B and FIG. 3C present the system of FIG. 3A in further detail. Asdescribed above, a sample cartridge interface 103 and an electrophoresisinterface 105 are comprised in the system, for engaging the samplecartridge and the electrophoresis cartridge. Both the sample cartridgeand the electrophoresis cartridge provided herein can be releasably orremovably engaged with the system. The system of FIG. 3A-C can be usedin forensic analysis to generate genetic information, such as an STRprofile, from a single sample. In some cases, the system may be used todetermine the genetic profile of a sample in less than about 6 hours, 5hours, 4 hours, 3 hours, 2.5 hours, 2 hours, 1.5 hours, 1 hour, 30minutes, 20 minutes, 10 minutes, 5 minutes 1 minute or less. Such timemay depend upon the number of steps included in sample processingoperations, for example.

A schematic of the system of FIG. 3A-C is illustrated in FIG. 3D. Achassis 200 is included for structural support, which may be formed of ametallic material, such as aluminum or steel, a polymeric material, or acombination thereof. In some cases, the chassis may be structured tominimize the weight of the system. A user interface which comprisessystem electronic controls 201, embedded computer 202, and a userinterface screen capable of identifying and reading fingerprint 204 andsample patch barcode 205, is included in the system. The user interfacereceives and processes requests or instructions from and deliversinformation to a user. It can include software programmed to executeroutines for performing the operations mentioned, above, and transmitand receive information, such as computer files, from remote locations,e.g., over the Internet. The user interface can also enable the user tomonitor the progress of the operation and make changes to the operationof system if measurements are not within selected parameters. A samplecartridge interface 206 is provided for receiving a sample cartridge forsample processing. The sample cartridge described herein can beconfigured to receive one or more samples and to perform at least one ofsample isolation, extraction, purification, biochemical reaction (e.g.,DNA amplification) or dilution, when the sample cartridge is engagedwith the sample cartridge interface of the system. Sample amplificationcan include polymerase chain reaction (PCR). One or more reagents thatare needed for performing one or more steps of sample processing may bepre-loaded or comprised in the sample cartridge, for example, washingbuffer, lysis buffer, diluent, or amplification reagents. Also comprisedin the system is a fully integrated electrophoresis cartridge 207 thatis releasably engageable with the system via an electrophoresiscartridge interface. The electrophoresis system comprises all essentialparts for performing an electrophoretic analysis, such as anelectrophoresis capillary, electrodes (e.g., anode and cathode),electrophoresis separation medium, or electrophoresis buffer. It mayfurther comprise one or more reagent containers for holding reagentsthat are used for sample processing, e.g., a lysis buffer container. Thelysis buffer may be placed in fluidic communication with the samplecartridge and used for isolating the target material out of the sampleduring sample processing, after both the sample cartridge and theelectrophoresis cartridge are engaged with the system. Once theengagement of the electrophoresis cartridge is completed, at least oneautomatic communication between the electrophoresis cartridge and thesystem may be established, for example, an electrical communication 213between the electrophoresis cartridge and the system electronic controls201, an optical communication 214 between a portion of theelectrophoresis capillary in the electrophoresis cartridge and an opticsmodule 203 of the system, a fluidic communication 215 between a sampleinlet port of the electrophoresis cartridge and a sample outlet port ofthe sample cartridge, a mechanical and thermal 216 communication betweenthe electrophoresis cartridge and a motorized drives and cooling module208 of the system. Accordingly, sample analysis can include isolation ofan analyte, such as DNA, from a sample, performance of a chemicalreaction on the analyte, such as PCR, to produce a reaction product(e.g., STR amplicons) and analysis of the reaction product, e.g.,detection and analysis reaction product by electrophoresis.

The system provided herein may further comprise a power source 212 forsupplying the power for the system, AC mains 211 for applying a voltagegradient across the anode and the cathode, one or more fans 210 fordissipate the heat for one or more parts of the system, and one or moreUSB ports 209 for collecting and transferring data either within thesystem or outside the system.

User Interface

FIGS. 4A-4AB illustrate a series of example graphical user interfacescreens that are displayed on a biometric biochemical analysis systemdisplay according to specific embodiments. These screens are provided asone illustrative example only. It will be apparent to one of skill inthe art that many modifications, substitutions, and rearrangements arepossible. It was also be apparent to one of skill in the art that anyportion of the screen may include video content where desired orhelpful, including animated diagrams. It will be further apparent thatone or more screens may be accompanied by appropriate audio output.

FIGS. 4A-4AB also illustrate examples of representative directedworkflows according to specific embodiments. As further describedherein, these workflows represent separate novel aspects when related toa biometric biochemical analysis system as discussed herein.

FIG. 4A, screen 1, illustrates an example optional login, or start, or“lock” interface according to specific embodiments. Note that in thisand other screens, text presented in italics is generally descriptive ofa screen region and is generally not displayed to a user. In thisexample screen, a user can login or authenticate herself or himself,either to begin a new session or continue a session in progress, byplacing a thumbprint or other print on an area indicated by the GUI.This area may be on the display itself or on some other reading portionof a biometric biochemical analysis system that is indicated by thesystem. In further embodiments, a biometric biochemical analysis systemincludes a camera that can perform user face detection that is active asprogrammed by the system (e.g. at all times when the system is on or atspecific times) and that recognizes and authorizes a user as soon as theuser is positioned near the system and/or when the user performs a touchor audio request for authentication. The screen further optionallyincludes a touch area or other input that can be activated to register anew user according to any user registration method.

FIG. 4B, screen 2, illustrates an example of user recognition orauthentication according to specific embodiments. Generally, a user willbe acknowledged as recognized and authenticated by a display of anofficial stored photograph of the user as shown. Alternately, a user'sname or other indicia (e.g. employee identification number) may bedisplayed or presented audibly. According to specific embodiments, theuser's identity will be shown on the display at various times throughoutthe collection process both to alert the user that he is still theauthenticated user and to allow possible other users to determinewhether a biometric biochemical analysis system is in use and by whom.

In certain embodiments, user authentication is automatic, that is, auser is authenticated without providing an active command to the system.For example, authentication can occur without providing any of: aphysical cue, such as touching a screen or pressing a button; a visualcue, such as providing a visual sign such as a waving motion, or verbalcue, such as announcing, “Hey, System”. In such an embodiment, thesystem can have a camera that continually or periodically scans theenvironment looking for any faces, and software that analyzes facialimages for a potential user. Using, e.g., facial recognition software,the system can match an image with an authorized user, and authenticatethe user. Facial recognition software is commercially available, e.g.,from Luxand (Alexandria, Va.) or iViewSystems (Oakville, Ontario, CA).Alternatively, a microphone can be on continuously or intermittently.Speaker recognition can recognize voices for authentication, and can doso without a prompt from a user to “listen” to a command. Speakerrecognition software is commercially available, e.g., from Sestek(Istanbul, Turkey). System operation can continue once a user isauthenticated.

FIG. 4C, screen 3, illustrates an example of a display directing a userto capture biometric data, in this example a set of fingerprints from asubject. The biometric data may be captured by an area of the display,such as a touch screen or reader or cameras integrated with the display.Alternatively, the biometric data may be captured by another module orcomponent of a biometric biochemical analysis system, in which case thelocation and operation of that module or component will be indicated onthe screen. This screen optionally also includes a “lock” icon to returna biometric biochemical analysis system to a “locked” status, thereafterrequiring a user to be authenticated again before performing furthertasks regarding this particular session or any session. The lock iconcan be repeated on various other screens as illustrated or as desiredand configured according to specific embodiments. This screen optionallyalso includes a user identification indication, in this case aphotograph shown on the upper right, to indicate to the user or toothers which user is actively performing a task on the biometricbiochemical analysis system. This identification indication can berepeated on various other screens as illustrated or as desired andconfigured according to specific embodiments. This screen optionallyalso includes a menu activation indication, in this case a graphic shownon the upper left, to allow a user to activate one or more menus of thebiometric biochemical analysis system as described further herein. Thisindication can be repeated on various other screens as illustrated or asdesired and configured according to specific embodiments. The menuspresented can be context sensitive providing different options or adifferent arrangement of options or submenus depending of the context ofthe activation. Optionally, the screen can also show an indication ofthe biometric data being captured and processes being performed, such asa search. In this example, a fingerprint capture is indicated with alive display shown of the captured data. Various information about thecapture can also be displayed, such as elapsed or expected time toprocess or store the capture, quality of the capture, indication thatthe capture should be repeated, etc.

FIG. 4D, screen 4, illustrates an example of a display indicating thatthe system is awaiting search results from a server, results from aremote database such as Integrated Automated Fingerprint IdentificationSystem (IAFIS). In this example, a fingerprint database is indicated.Various information about the search can also be displayed, such aselapsed or expected time, database to be searched, number of recordssearched, etc.

FIGS. 4E-4F, screens 5 and 6, illustrate an example of a displaydirecting a user to perform one or more steps to prepare a biologicsample. As elsewhere described herein, display of this screen may beconditional on results from a fingerprint search or results of someother action of the biometric biochemical analysis system. As elsewheredescribed herein, a biometric biochemical analysis system for one ormore reasons may determine that collection of a particular biologicsample is or is not desirable, needed, or authorized. In this example,directions are illustrated showing a user how to take a saliva samplefrom a subject using a “swab” or similar device. As will be understoodfrom the discussion herein to one of ordinary skill in the art, displayof one or more subsequent screens is conditional on whether this screenis activated for sample collection.

FIG. 4G, screen 7, illustrates an example of a display directing a userto scan a code associated with a sample (e.g., a bar code or QR codeassociated with a swab or swab container or envelope). In this example,a live camera image of the code is displayed along with the recognizedcode contents.

FIG. 4H, screen 8, illustrates an example of a display directing a userto perform one or more steps to place or submit a sample at or in acorrect portion of the biometric biochemical analysis system. Aselsewhere described herein, display of this screen may be conditional onresults from a fingerprint search or results of some other action of thebiometric biochemical analysis system. In this example, directions areillustrated showing a user how to take one saliva swab from an envelopeor container that has been registered to the system and place that swabinto an analysis portion of the biometric biochemical analysis system.”

FIGS. 4I, 4J and 4K, screens 9, 10, and 11, illustrate a timer displayedaccording to specific embodiments. This timer is displayed becausebiologic analysis can take substantial time, e.g., 60 minutes. The timeralerts the user or other users that the biometric biochemical analysissystem is performing a biochemical analysis that generally can only bepaused or aborted by the user that initiated the analysis or optionallyanother user specifically authorized to abort such analysis. Asdescribed elsewhere herein, this screen may optionally include an iconor indication, such as the menu indication at the top left, that allowsa user to use the biometric biochemical analysis system for further datacollection of a current subject or a different subject while theanalysis proceeds.

FIG. 4L, screen 12 illustrates an example of screen directing a user toremove a spent or completed component from a system, in this case asample for which analysis is complete.

FIG. 4M, screen 13 illustrates one example of a task complete screen. Inthis example, the completed task is the analysis and the example screenindicates an identification number for the subject and/or the analysis.The screen also indicates a back end cartridge (BEC) icon and a numberof analysis (e.g. “25”) that can be performed before the BEC must bereplaced.

FIG. 4N, screen 14 illustrates one example of directing a user to take aconfirmation action or confirmatory data with respect to a biometricdata collection task. In this example, a user is directed to againfingerprint a subject with respect to a DNA sample collection to confirmthe subject matches the analyzed DNA. Note, this confirmatory action maytake place at any time with respect to the workflow as is required bylegal or institutional authorities. Other confirmatory tasks may includea video recording of a subject having a sample collected and/or holdinga labeled sample once collected, an audio recording of a subject readingout a sample number, etc. These confirmatory tasks can be prompted atthe start or end of sample analysis or during collection.

FIGS. 4O, 4P and 4Q, screens 15, 16, and 17, illustrate an example of adisplay directing a user to perform one or more steps to place one ormore reagents, supplies, or other supplemental or support components ina correct location of the biometric biochemical analysis system. Displayof this screen is generally triggered by a biometric biochemicalanalysis system automatically detecting that the particular supplies areneeded or must be replaced. Replacement may be indicated according to alevel or available supply or according to other triggers such as anexpiration date. These example screens illustrate directing a user toremove a BEC from the appropriate position on the biometric biochemicalanalysis system and to place a new or refilled BEC into the biometricbiochemical analysis system. Screen 18, FIG. 4R, as described above,displays a task successfully complete indication, in this case insertionof a new BEC.

Screen 19, FIG. 4S, in this example embodiment, illustrates directing auser to place a calibration or verification sample packet into theappropriate position on the biometric biochemical analysis system.Screens 20 and 21, FIGS. 4T and 4U, in this example embodiment,illustrate a timer indicating time left for completing a calibrationprocess. Screen 22, FIG. 4V, in this example embodiment, illustrates thesystem's successful completion of the calibration process. Screen 23,FIG. 4W, in this example embodiment, illustrates directing a user toremove a calibration or verification sample packet from the appropriateposition on the biometric biochemical analysis system once calibrationor verification is complete. Screen 24, FIG. 4X, in this exampleembodiment, illustrates indication of successful completion of thecalibration process and that a specific number of analysis (e.g. “200”)can be performed with the newly installed and calibrated BEC.

FIGS. 4Y, 4Z, 4AA and 4AB, screens 25, 26, 27, and 28, illustrateexamples of menu, submenu, static help, and live help that can beprovided to a user by a biometric biochemical analysis system accordingto specific embodiments. Example menu items shown in screen 25 includeicons for help (e.g., “?” icon), returning to a login or fingerprintscreen (fingerprint icon), order supplies (shopping cart icon), or setup(gear icon). Example help submenu items shown in screen 26 include iconsfor displaying help instructions (book icon), watching instructional ortraining videos (video icon), connecting to a live or automated helpexpert via audio or video (headset icon). Any number of further menus,options, and help functions can be provided as will be understood in theart.

While various types of assistance provided at computers and informationdevices are known, providing sophisticated multi-level help directly ata biometric biochemical analysis system according to specificembodiments presents novel assistance at such a device for anon-technical user. In particular, because the various components of thedevice are operationally and for many components physically integrated,any static context sensitive help or live help can easily determine theexact physical condition of the device and can provide assistance thatactivates or controls various aspects or modules of the device.

Computer Control Systems

FIG. 6 shows a computer system that is programmed or otherwiseconfigured to provide step by step user instructions for biologic samplecollection and analysis and biometric data capture preparation,processing and/or analysis. FIG. 6 shows a computer system 801 that isprogrammed or otherwise configured to facilitate sample preparation,processing and/or analysis. The computer system 801 can regulate variousaspects of sample preparation, processing and/or analysis of the presentdisclosure, such as, for example, engaging an electrophoresis cartridgewith an electrophoresis interface of a system for sample preparation,processing and/or analysis (see, e.g., FIGS. 1A-1C). The computer system801 can be integrated with such system.

The computer system 801 includes a central processing unit (CPU, also“processor” and “computer processor” herein) 805, which can be a singlecore or multi core processor, or a plurality of processors for parallelprocessing. The computer system 801 also includes memory or memorylocation 810 (e.g., random-access memory, read-only memory, flashmemory), electronic storage unit 815 (e.g., hard disk), communicationinterface 820 (e.g., network adapter) for communicating with one or moreother systems, and peripheral devices 825, such as cache, other memory,data storage and/or electronic display adapters. The memory 810, storageunit 815, interface 820 and peripheral devices 825 are in communicationwith the CPU 805 through a communication bus (solid lines), such as amotherboard. The storage unit 815 can be a data storage unit (or datarepository) for storing data. The computer system 801 can be operativelycoupled to a computer network (“network”) 830 with the aid of thecommunication interface 820. The network 830 can be the Internet, anInternet and/or extranet, or an intranet and/or extranet that is incommunication with the Internet. The network 830 in some cases is atelecommunication and/or data network. The network 830 can include oneor more computer servers, which can enable distributed computing, suchas cloud computing. The network 830, in some cases with the aid of thecomputer system 801, can implement a peer-to-peer network, which mayenable devices coupled to the computer system 801 to behave as a clientor a server.

The CPU 805 can execute a sequence of machine-readable instructions,which can be embodied in a program or software. The instructions may bestored in a memory location, such as the memory 810. The instructionscan be directed to the CPU 805, which can subsequently program orotherwise configure the CPU 805 to implement methods of the presentdisclosure. Examples of operations performed by the CPU 805 can includefetch, decode, execute, and writeback.

The CPU 805 can be part of a circuit, such as an integrated circuit. Oneor more other components of the system 801 can be included in thecircuit. In some cases, the circuit is an application specificintegrated circuit (ASIC).

The storage unit 815 can store files, such as drivers, libraries andsaved programs. The storage unit 815 can store user data, e.g., userpreferences and user programs. The computer system 801 in some cases caninclude one or more additional data storage units that are external tothe computer system 801, such as located on a remote server that is incommunication with the computer system 801 through an intranet or theInternet.

The computer system 801 can communicate with one or more remote computersystems through the network 830. For instance, the computer system 801can communicate with a remote computer system of a user (e.g.,operator). Examples of remote computer systems include personalcomputers (e.g., portable PC), slate or tablet PC's (e.g., Apple® iPad,Samsung® Galaxy Tab), telephones, Smart phones (e.g., Apple® iPhone,Android-enabled device, Blackberry®), or personal digital assistants.The user can access the computer system 801 via the network 830.

Methods as described herein can be implemented by way of machine (e.g.,computer processor) executable code stored on an electronic storagelocation of the computer system 801, such as, for example, on the memory810 or electronic storage unit 815. The machine executable or machinereadable code can be provided in the form of software. During use, thecode can be executed by the processor 805. In some cases, the code canbe retrieved from the storage unit 815 and stored on the memory 810 forready access by the processor 805. In some situations, the electronicstorage unit 815 can be precluded, and machine-executable instructionsare stored on memory 810.

The code can be pre-compiled and configured for use with a machine havea processer adapted to execute the code, or can be compiled duringruntime. The code can be supplied in a programming language that can beselected to enable the code to execute in a pre-compiled or as-compiledfashion.

Aspects of the systems and methods provided herein, such as the computersystem 801, can be embodied in programming. Various aspects of thetechnology may be thought of as “products” or “articles of manufacture”typically in the form of machine (or processor) executable code and/orassociated data that is carried on or embodied in a type of machinereadable medium. Machine-executable code can be stored on an electronicstorage unit, such memory (e.g., read-only memory, random-access memory,flash memory) or a hard disk. “Storage” type media can include any orall of the tangible memory of the computers, processors or the like, orassociated modules thereof, such as various semiconductor memories, tapedrives, disk drives and the like, which may provide non-transitorystorage at any time for the software programming. All or portions of thesoftware may at times be communicated through the Internet or variousother telecommunication networks. Such communications, for example, mayenable loading of the software from one computer or processor intoanother, for example, from a management server or host computer into thecomputer platform of an application server. Thus, another type of mediathat may bear the software elements includes optical, electrical andelectromagnetic waves, such as used across physical interfaces betweenlocal devices, through wired and optical landline networks and overvarious air-links. The physical elements that carry such waves, such aswired or wireless links, optical links or the like, also may beconsidered as media bearing the software. As used herein, unlessrestricted to non-transitory, tangible “storage” media, terms such ascomputer or machine “readable medium” refer to any medium thatparticipates in providing instructions to a processor for execution.

Hence, a machine readable medium, such as computer-executable code, maytake many forms, including but not limited to, a tangible storagemedium, a carrier wave medium or physical transmission medium.Non-volatile storage media include, for example, optical or magneticdisks, such as any of the storage devices in any computer(s) or thelike, such as may be used to implement the databases, etc. shown in thedrawings. Volatile storage media include dynamic memory, such as mainmemory of such a computer platform. Tangible transmission media includecoaxial cables; copper wire and fiber optics, including the wires thatcomprise a bus within a computer system. Carrier-wave transmission mediamay take the form of electric or electromagnetic signals, or acoustic orlight waves such as those generated during radio frequency (RF) andinfrared (IR) data communications. Common forms of computer-readablemedia therefore include for example: a floppy disk, a flexible disk,hard disk, magnetic tape, any other magnetic medium, a CD-ROM, DVD orDVD-ROM, any other optical medium, punch cards paper tape, any otherphysical storage medium with patterns of holes, a RAM, a ROM, a PROM andEPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wavetransporting data or instructions, cables or links transporting such acarrier wave, or any other medium from which a computer may readprogramming code and/or data. Many of these forms of computer readablemedia may be involved in carrying one or more sequences of one or moreinstructions to a processor for execution.

The computer system 801 can include or be in communication with anelectronic display 835 that comprises a user interface (UI) 840, forexample, for enabling the user to instruct the computer system 801 tobegin sample preparation, processing and/or analysis. Examples of UI'sinclude, without limitation, a graphical user interface (GUI) andweb-based user interface.

Methods and systems of the present disclosure can be implemented by wayof one or more algorithms. An algorithm can be implemented by way ofsoftware upon execution by the central processing unit 805. Thealgorithm can, for example, implement the general operation of a systemfor sample preparation, processing and/or analysis. In some examples,the algorithm can regulate the sequential opening and closing of valvesor the operation of an electrophoresis cartridge.

Embodiment in a Programmed Information Appliance

FIG. 5 is a block diagram showing a representative example logic devicein which various aspects of the present invention may be embodied. Aswill be understood to practitioners in the art from the teachingsprovided herein, the invention can be implemented in hardware and/orsoftware. In some embodiments of the invention, different aspects of theinvention can be implemented in either client-side logic or server-sidelogic. As will be understood in the art, the invention or componentsthereof may be embodied in a fixed media program component containinglogic instructions and/or data that when loaded into an appropriatelyconfigured computing device cause that device to perform according tothe invention. As will be understood in the art, a fixed mediacontaining logic instructions may be delivered to a user on a fixedmedia for physically loading into a user's computer or a fixed mediacontaining logic instructions may reside on a remote server that a useraccesses through a communication medium in order to download a programcomponent.

FIG. 5 shows an information appliance (or digital device) 700 that maybe understood as a logical apparatus that can read instructions frommedia 717 and/or network port 719, which can optionally be connected toserver 720 having fixed media 722. Apparatus 700 can thereafter usethose instructions to direct server or client logic, as understood inthe art, to embody aspects of the invention. One type of logicalapparatus that may embody the invention is a computer system asillustrated in 700, containing CPU 707, optional input devices 709 and711; disk drives 715 and optional monitor 705. Fixed media 717, or fixedmedia 722 over port 719, may be used to program such a system and mayrepresent a disk-type optical or magnetic media, magnetic tape, solidstate dynamic or static memory, etc. In specific embodiments, theinvention may be embodied in whole or in part as software recorded onthis fixed media. Communication port 719 may also be used to initiallyreceive instructions that are used to program such a system and mayrepresent any type of communication connection.

The invention also may be embodied in whole or in part within thecircuitry of an application specific integrated circuit (ASIC) or aprogrammable logic device (PLD). In such a case, the invention may beembodied in a computer understandable descriptor language, which may beused to create an ASIC, or PLD that operates as herein described.

Other Embodiments

The invention has now been described with reference to specificembodiments. Other embodiments will be apparent to those of skill in theart. In particular, a user digital information appliance has generallybeen illustrated as a personal computer. However, the digital computingdevice is meant to be any information appliance for interacting with aremote data application, and could include such devices as a digitallyenabled television, cell phone, personal digital assistant, laboratoryor manufacturing equipment, etc. It is understood that the examples andembodiments described herein are for illustrative purposes and thatvarious modifications or changes in light thereof will be suggested bythe teachings herein to persons skilled in the art and are to beincluded within the spirit and purview of this application and scope ofthe claims.

Furthermore, various different actions can be used to effectcommunication between a user and a biometric biochemical analysissystem. For example, a voice command may be spoken by the user, a key orscreen area may be indicated, a button or screen area on an associatedmodule or component may be indicated, or selection using any pointingdevice may be effected by the user.

All publications, patents, and patent applications cited herein or filedwith this application, including any references filed as part of anInformation Disclosure Statement, are incorporated by reference in theirentirety.

The general structure and techniques, and more specific embodiments thatcan be used to effect different ways of carrying out the more generalgoals are described herein.

Although only a few embodiments have been disclosed in detail above,other embodiments are possible and the inventor (s) intend these to beencompassed within this specification. The specification describesspecific examples to accomplish a more general goal that may beaccomplished in another way. This disclosure is intended to beexemplary, and the claims are intended to cover any modification oralternative that might be predictable to a person having ordinary skillin the art.

Also, the inventors intend that only those claims which use the words“means for” are intended to be interpreted under 35 USC 112, sixthparagraph. Moreover, no limitations from the specification are intendedto be read into any claims, unless those limitations are expresslyincluded in the claims. The logic components described herein may be anykind of components, either general purpose, or some specific purposecomponents. The component architecture may be an Intel or AMD basedarchitecture or any other logic processing architecture. An operatingsystem, such as Linux, Unix, Windows, etc. may be included to providevarious information handling functions. One or more components mayinclude a handheld computer, such as a PDA, cellphone, or laptop, ahandheld camera, etc.

The programs may be written in C or Python, or Java, Brew or any otherprogramming language. The programs may be resident on a storage medium,e.g., magnetic or optical, e.g. the computer hard drive, a removabledisk or media such as a memory stick or SD media, wired or wirelessnetwork based or Bluetooth based Network Attached Storage (NAS), orother removable medium, or other removable medium. The programs may alsobe run over a network, for example, with a server or other machinesending signals to the local machine, which allows the local machine tocarry out the operations described herein.

Where a specific numerical value is mentioned herein, it should beconsidered that the value may be increased or decreased by 20%, whilestill staying within the teachings of the present application, unlesssome different range is specifically mentioned. Where a specifiedlogical sense is used, the opposite logical sense is also intended to beencompassed.

Software Implementations

Various embodiments involving methods and/or systems for biometric oridentifying information can be implemented on a general purpose orspecial purpose information handling appliance or logic enabled system,such as a laboratory or diagnostic or production system, using asuitable programming language such as perl, python, Java, C++, C#,Cobol, C, Pascal, Fortran, PL1, LISP, assembly, etc., and any suitabledata or formatting specifications, such as HTML, XML, dHTML, TIFF, JPEG,tab-delimited text, binary, etc. In the interest of clarity, not allfeatures of an actual implementation are described in thisspecification. It will be understood that in the development of any suchactual implementation (as in any software development project), numerousimplementation-specific decisions must be made to achieve thedevelopers' specific goals and subgoals, such as compliance withsystem-related and/or business-related constraints, which will vary fromone implementation to another. Moreover, it will be appreciated thatsuch a development effort might be complex and time-consuming, but wouldnevertheless be a routine undertaking of software engineering for thoseof ordinary skill having the benefit of this disclosure.

Furthermore, it is well known in the art that logic systems and methodssuch as described herein can include a variety of different componentsand different functions in a modular fashion. Different embodiments ofthe invention can include different mixtures of elements and functionsand may group various functions as parts of various elements. Forpurposes of clarity, the invention is described in terms of systems thatinclude many different innovative components and innovative combinationsof innovative components and known components. No inference should betaken to limit the invention to combinations containing all of theinnovative components listed in any illustrative embodiment in thisspecification.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. It is not intendedthat the invention be limited by the specific examples provided withinthe specification. While the invention has been described with referenceto the aforementioned specification, the descriptions and illustrationsof the embodiments herein are not meant to be construed in a limitingsense. Numerous variations, changes, and substitutions will now occur tothose skilled in the art without departing from the invention.Furthermore, it shall be understood that all aspects of the inventionare not limited to the specific depictions, configurations or relativeproportions set forth herein which depend upon a variety of conditionsand variables. It should be understood that various alternatives to theembodiments of the invention described herein may be employed inpracticing the invention. It is therefore contemplated that theinvention shall also cover any such alternatives, modifications,variations or equivalents. It is intended that the following claimsdefine the scope of the invention and that methods and structures withinthe scope of these claims and their equivalents be covered thereby.

1. A system comprising: (I) an authentication sub-system comprising acamera and/or a microphone, and (II) a biochemical analysis sub-systemconfigured to perform a biochemical analysis on a biological sampleprovided to the biochemical analysis sub-system; wherein the system isconfigured to: (a) authenticate a user by facial recognition based onone or more images taken by the camera or by voice recognition based onvoice sound picked up by the microphone, wherein authentication proceedswithout an active command from the user; (b) instruct an authenticateduser to provide a biological sample to the biochemical analysissub-system; (c) without further user input, automatically execute abiochemical analysis on a provided biological sample. 2.-9. (canceled)10. A method comprising: (a) without an active command from a user,using an authentication sub-system of a system to collect one or morecamera images of a user and authenticating the based on the images; (b)instructing an authenticated user through a user interface on the systemto provide a biological sample to a biochemical analysis sub-system ofthe system; and (c) without further user input, automatically executinga biochemical analysis on a provided biological sample.
 11. (canceled)12. A method of collecting biometric data from one or more subjectscomprising: configuring a biometric capture and biochemical analysissystem having at least one logic processor, data storage, at least onebiological sample receiver, at least one electronic biometric datacapture interface, at least one biochemical analyzer, at least onecommunications interface, and at least one user presentation interfaceto perform steps comprising: using the user presentation interface todirect a user to prepare a biologic sample and/or to place a biologicsample into a receptacle of the biometric biochemical analysis system;using the user presentation interface to direct said user or a differentuser to collect electronically captured biometric data from a subjectusing one or more digital biometric data capture devices; performing abiochemical analysis of the sample using the biochemical analyzer toproduce a set of biochemical biometric data; and storing resultsindicating biochemical biometric data or electronically capturedbiometric data or both in system memory and/or communicating the resultsto one or more additional computer systems over the communicationsinterface. 13.-33. (canceled)
 34. A method for collection and analysisof biometric data from subjects by non-technical users at an integratedbiometric data collection and analysis system, the system comprising alogic processor operationally connected to: a memory, a user interface,a biometric data collection component, a biological sample receiver, abiochemical analysis component, and a communications component, themethod comprising: configuring the at least one logic processor of thesystem to execute a logic routine able to: authenticate a user using theuser interface; direct the user using the user interface to inputinitial data regarding a subject using the user interface or thebiometric data capture component or both; perform an initial searchusing the initial data and indicate to a user progress of the initialsearch using the user interface; determine if a biometric sample shouldbe collected and, if yes, direct the user using the user interface howto do any of: collect the biologic sample, identify the sample to thesystem, or place the sample into the biological sample receiver forbiologic analysis; on completion of a biologic analysis, transferbiologic analysis data results for forensic identification; optionally,indicate to a user progress of the biologic analysis and progress of thetransfer using the user interface; optionally, indicate to a user whento remove the sample from the system and further handling of the sample;receive data regarding forensic identification; and present dataregarding forensic identification to the user using the user interface.35. A system for collecting biometric data from one or more subjectscomprising: at least one logic processor; data storage; at least onebiological sample receiver; at least one electronic biometric datacapture module; at least one biochemical analyzer module; at least onecommunications module; at least one user presentation module; andwherein the processor is configurable with logic instructions to enablethe system to perform the method of: using the user presentation moduleto direct said user or a different user to collect electronicallycaptured biometric data from a subject using the digital biometric datamodule; using the user presentation module to direct a user to place abiologic sample into a biological sample receiver and/or to prepare abiologic sample; performing a biochemical analysis of the sample toproduce a set of biochemical biometric data; and communicating resultsindicating biochemical biometric data or electronically capturedbiometric data or both to one or more additional computer systems overthe communications interface.
 36. The system according to claim 35wherein the at least one biological sample receiver comprises one ormore of: a cartridge receiver; a cartridge receiver and a cartridge; aliquid sample receiver; a solid sample receiver.
 37. The systemaccording to claim 35 wherein the least one electronic biometric datacapture module comprises one or more of: one or more scanners or camerasfor capturing images or scanning data from one or more of: a face or anyother part of a body or clothing useful in identification; prints offingers, palms, feet, toes; a sample or a sample with a bar code, RFIDcode, or other code; and an identification card or birth certificate ordeath certificate or other papers; a retinal scan; one or more audiorecorders for capturing a voice print or other audio data; one or moreinterfaces for attaching to external data capture devices.
 38. Thesystem according to claim 35 wherein the at least one electronicbiometric data capture module comprises one or more of: a still camera;a video camera; an infrared camera or other heat detecting or imagingdevices; a scanner for scanning finger prints, hand prints, or footprints; a retina scanner; a facial scanner; a microphone for recordingaudio data; and one or more interfaces to connecting to any externalcapture device.
 39. The system according to claim 35 wherein the atleast one biochemical analyzer comprises one or more of: anelectrophoresis analyzer; one or more other analyzers or detectors; oneor more sample cartridge interfaces; one or more interfaces forattaching to external analyzers or detectors.
 40. The system accordingto claim 28 wherein the logic processor is configured to executeinstructions to perform a biochemical reaction on a sample in a samplecartridge engaged with the cartridge interface to produce a reactionproduct and to analyze the reaction product.
 41. The system according toclaim 35 further comprising at least one additional analyzers ordetectors.
 42. The system according to claim 41 wherein the at least oneadditional analyzers or detectors comprises one or more of: one or moremedical examination detectors able to determine one or more of heartrate, temperature, blood pressure, or other medical parameters; one ormore detectors for detecting drugs or alcohol or other parameters frombody sample such as hair, blood, skin, or urine; one or more detectorsfor detecting drugs or alcohol or other parameters from a breath sample.43. The system according to claim 35 wherein the at least onecommunications interface comprises one or more of: a wired or wirelessconnection to a local area network; a wired or wireless connection to anexternal connection, such as the internet; and a wired or wirelessconnection to one or more local devices or systems.
 44. The systemaccording to claim 35 wherein the at least one user presentationinterface comprises one or more of: one or more multipurpose displaysfor presenting video, image, or text content; one or more audio devicesfor presenting audio content; one or more visual or audio indicators forindicating a state of a particular part of component of the system; oneor more interfaces for external presentation devices.
 45. The systemaccording to claim 35 wherein system components are operationallyconnected into effectively one system with a user presentation interfaceconfigured to direct collection of both a sample and to capturebiometric data.
 46. The system according to claim 45 wherein a pluralityof said modules are configured into a physical housing that provides asubstantially unified physical system.
 47. The system according to claim35 wherein the processor is further configurable to use one or more ofsaid modules to: authenticate a user.
 48. The system according to claim35 wherein the processor is further configurable to use one or more ofsaid modules to direct a user to collect a biologic sample from one ormore subjects.
 49. The system according to claim 48 wherein the samplecan be one or more selected from the group consisting of: saliva, blood,semen, hair, tissues, bodily fluids, a non-living substance suspected ofbeing contaminated with DNA, a swab or other instrument used to samplesubstances suspected of containing DNA.
 50. The system according toclaim 48 wherein the one or more subjects can be one or more selectedfrom the group consisting of: a person being detained, a newborn; aliving or deceased victim of an accident or natural disaster, a livingor deceased casualty of a military action; a living or deceased victimof a crime or other act of violence; a living or deceased unidentifiedperson; any person; domesticated animals such as livestock, racinganimals, pets; wild animals such as research subjects or fisheriescatch. 51.-65. (canceled)